MEDTECH PRODS
FDA Approved Drugs

MEDTECH PRODS

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

OTC RX Discontinued
  • Total Records 12
  • Latest Approval Date Jun 17, 2003
  • Data Source FDA
  • First Approval Date Aug 15, 1984
All
12
View
Discontinued
1
View
OTC
10
View
RX
1
View
Company Overview

Company

MEDTECH PRODS

Country

Australia

Website

Visit Website

Email

hq@medtechglobal.com

Social Profiles

Company Snapshot

MEDTECH PRODS

Medtech Global Ltd

Australia

medtechglobal.com/ind/ hq@medtechglobal.com View on Map
FDA Approved Drug Records ( 12 records )
2001
29 Jun
OTC Application: 21308

Drug Name

MONISTAT 1 COMBINATION PACK

Product Number

1

Dosage Form

-

Strength

2%,1.2GM

Approval Date

2001-06-29

21308 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

21308

Product Number

1

Dosage Form

-

Strength

2%,1.2GM

Approval Date

2001-06-29

Regulatory Status

OTC

1984
15 Aug
RX Application: 18888

Drug Name

MONISTAT 3

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1984-08-15

18888 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

18888

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1984-08-15

Regulatory Status

RX

1998
30 Mar
OTC Application: 20827

Drug Name

MONISTAT 3

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1998-03-30

20827 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

20827

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1998-03-30

Regulatory Status

OTC

1996
16 Apr
OTC Application: 20670

Drug Name

MONISTAT 3 COMBINATION PACK

Product Number

2

Dosage Form

-

Strength

2%,200MG

Approval Date

1996-04-16

20670 / 2

Active Ingredient

MICONAZOLE NITRATE

Application Number

20670

Product Number

2

Dosage Form

-

Strength

2%,200MG

Approval Date

1996-04-16

Regulatory Status

OTC

2003
17 Jun
OTC Application: 21261

Drug Name

MONISTAT 3 COMBINATION PACK

Product Number

3

Dosage Form

-

Strength

2%,4%

Approval Date

2003-06-17

21261 / 3

Active Ingredient

MICONAZOLE NITRATE

Application Number

21261

Product Number

3

Dosage Form

-

Strength

2%,4%

Approval Date

2003-06-17

Regulatory Status

OTC

2001
02 Feb
OTC Application: 21261

Drug Name

MONISTAT 3 COMBINATION PACK (PREFILLED)

Product Number

1

Dosage Form

-

Strength

2%,4%

Approval Date

2001-02-02

21261 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

21261

Product Number

1

Dosage Form

-

Strength

2%,4%

Approval Date

2001-02-02

Regulatory Status

OTC

1991
15 Feb
OTC Application: 17450

Drug Name

MONISTAT 7

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1991-02-15

17450 / 2

Active Ingredient

MICONAZOLE NITRATE

Application Number

17450

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1991-02-15

Regulatory Status

OTC

1991
15 Feb
OTC Application: 18520

Drug Name

MONISTAT 7

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1991-02-15

18520 / 2

Active Ingredient

MICONAZOLE NITRATE

Application Number

18520

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1991-02-15

Regulatory Status

OTC

1993
26 Apr
OTC Application: 20288

Drug Name

MONISTAT 7 COMBINATION PACK

Product Number

2

Dosage Form

-

Strength

2%,100MG

Approval Date

1993-04-26

20288 / 2

Active Ingredient

MICONAZOLE NITRATE

Application Number

20288

Product Number

2

Dosage Form

-

Strength

2%,100MG

Approval Date

1993-04-26

Regulatory Status

OTC

1990
02 May
OTC Application: 19918

Drug Name

NIX

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1990-05-02

19918 / 1

Active Ingredient

PERMETHRIN

Application Number

19918

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1990-05-02

Regulatory Status

OTC

1995
19 Jun
Discontinued Application: 20238

Drug Name

TAGAMET HB

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-06-19

20238 / 1

Active Ingredient

CIMETIDINE

Application Number

20238

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-06-19

Regulatory Status

Discontinued

1996
21 Aug
OTC Application: 20238

Drug Name

TAGAMET HB

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-08-21

20238 / 2

Active Ingredient

CIMETIDINE

Application Number

20238

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-08-21

Regulatory Status

OTC

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Drug Status Breakdown
12 total
  • OTC
  • RX
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

MONISTAT 1 COMBINATION PACK

Application Number

21308

Product Number

1

Active Ingredient

MICONAZOLE NITRATE

Dosage Form

-

Strength

2%,1.2GM

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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